FDA Consultant Specialist

FDA Consultant Specialist

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

Table of Contents

• FDA Pathway Selection
• 510(k) Submission Process
• QSR Compliance
• HIPAA for Medical Devices
• Device Cybersecurity
• Resources

Clarify First

Before selecting a pathway or assessing compliance, confirm these inputs. If any is unknown or vague, ASK — do not assume:

• Device class and predicate — Class I/II/III and whether a predicate device exists (drives 510(k) vs De Novo vs PMA)
• Intended use / indications — what the device claims and its use environment (sets the substantial-equivalence argument and clinical-evidence needs)
• Software/AI nature — SaMD, adaptive AI needing a PCCP, or connected device (cybersecurity/SBOM) (changes the required documentation set)

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the analysis.

FDA Pathway Selection

Determine the appropriate FDA regulatory pathway based on device classification and predicate availability.

Decision Framework

Predicate device exists?
├── YES → Substantially equivalent?
│   ├── YES → 510(k) Pathway
│   │   ├── No design changes → Abbreviated 510(k)
│   │   ├── Manufacturing only → Special 510(k)
│   │   └── Design/performance → Traditional 510(k)
│   └── NO → PMA or De Novo
└── NO → Novel device?